Metoprolol Succinate (Page 6 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
Metoprolol Succinate Extended-Release Tablets, USP are available containing 23.75 mg, 47.5 mg, 95 mg or 190 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg or 200 mg of metoprolol tartrate, USP, respectively.
25 mg tablets: White to off white, oval shape, biconvex film coated tablet with breakline on one side and debossed with ‘A’ and ‘3’ on each side of breakline on other side. They are available as follows:
67877-590-30 Bottles of 30 tablets
67877-590-60 Bottles of 60 tablets
67877-590-01 Bottles of 100 tablets
67877-590-05 Bottles of 500 tablets
67877-590-10Bottles of 1000 tablets
50 mg tablets: White to off white, round shape, biconvex film coated tablet with breakline on one side and debossed with ‘A50’ on other side. They are available as follows:
67877-591-30 Bottles of 30 tablets
67877-591-60 Bottles of 60 tablets
67877-591-01 Bottles of 100 tablets
67877-591-05 Bottles of 500 tablets
67877-591-10 Bottles of 1000 tablets
100 mg tablets: White to off white, round shape, biconvex film coated tablet with breakline on one side and debossed with ‘A100’ on other side. They are available as follows:
67877-592-30 Bottles of 30 tablets
67877-592-60 Bottles of 60 tablets
67877-592-01 Bottles of 100 tablets
67877-592-05 Bottles of 500 tablets
67877-592-10 Bottles of 1000 tablets
200 mg tablets: White to off white, oval shape, biconvex film coated tablet with breakline on one side and debossed with ‘A200’ on other side. They are available as follows:
67877-593-30 Bottles of 30 tablets
67877-593-60 Bottles of 60 tablets
67877-593-01 Bottles of 100 tablets
67877-593-05 Bottles of 500 tablets
67877-593-10 Bottles of 1000 tablets
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
17 PATIENT COUNSELING INFORMATION
Advise patients to take metoprolol succinate extended-release tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue metoprolol succinate extended-release tablets without consulting the physician.
Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with metoprolol succinate extended-release tablets have been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking metoprolol succinate extended-release tablets.
Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
Risk of hypoglycemia
Inform patients or caregivers that there is a risk of hypoglycemia when metoprolol succinate extended-release tablets are given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia. [see Warnings and Precautions (5.7)].
The brands listed are trademarks of their respective owners.
Manufactured by:
Alkem Laboratories Ltd.,
INDIA.
Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised: March, 2023
PT2937-05
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 67877-590-30
25mg
30 Tablets Rx Only
NDC 67877-591-30
50mg
30 Tablets
Rx Only
NDC 67877-592-30
100mg
30 Tablets
Rx Only
NDC 67877-593-01
200mg
100 Tablets Rx Only
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release | ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
|
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release | ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
|
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release | ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
|
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release | ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||
|
Labeler — Ascend Laboratories, LLC (141250469) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Alkem Laboratories Limited | 915628612 | MANUFACTURE (67877-590), MANUFACTURE (67877-591), MANUFACTURE (67877-592), MANUFACTURE (67877-593) |
Revised: 07/2023 Ascend Laboratories, LLC
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/metoprolol-succinate-40/page/6/